MAUDE Adverse Event Report: SISTEMAS MEDICOS ALARIS S.A. DE C.V. BD EXT SET DEHP FREE; INTRAVASCULAR ADMINISTRATION SET

Catalog Number	11088483
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/19/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The date received by manufacturer has been used for this field.If a device evaluation and/or device history review is completed, a supplemental report will be filed.
Event or Problem Description
Material# 11088483, batch #unknown.It was reported that the bd ext set dehp free had a component damage - leak.The following information was provided by the initial reporter: "the plastic hub of the tubing that twists to connect to pt snapped off which led the tubing to no longer being able to secure to clear link of pt's central line." verbatim rcc received a complaint via email.Email(s) attached.Item: 11088483 quantity affected: 1 ea serial/lot number: unk po : (b)(4) are any samples available for return? yes reported issue: med line syringe tubing (appears to be 1.5ml but this reporter did not set up the tubing) when detaching med line tubing from central line to administer an urgent prn med, the plastic hub of the tubing that twists to connect to pt snapped off which led the tubing to no longer being able to secure to clear link of pt's central line.Med (ampicillin) had been running and paused to administer urgent sedation, so med had to be paused further to be re-primed with a new med no further details provided by customer.
Event or Problem Description
No additional info.
Additional Manufacturer Narrative
No product or photo was returned by the customer.The customer complaint that the plastic hub separated from the set could not be verified due to the product not being returned for failure investigation.A device history record review could not be performed because a model and lot number was not provided by the customer.Due to no sample being received, an investigation could not be performed and a root cause could not be determined.

• Brand Name: BD EXT SET DEHP FREE
• Common Device Name: INTRAVASCULAR ADMINISTRATION SET
• Manufacturer (Section D): SISTEMAS MEDICOS ALARIS S.A. DE C.V.; blvd. insurgentes no. 20351; parque industrial el florido; tijuana
• Manufacturer (Section G): SISTEMAS MEDICOS ALARIS S.A. DE C.V.; blvd. insurgentes no. 20351; parque industrial el florido; tijuana
• Manufacturer Contact: helen cox (mdr) ; 75 north fairway drive; vernon hills, IL 60061 ; 8473935694
• MDR Report Key: 19312960
• Report Number: 9616066-2024-00752
• Device Sequence Number: 6942714
• Product Code: FPA
• UDI-Device Identifier: 10885403234668
• UDI-Public: (01)10885403234668
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K790108
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/05/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 11088483
• Device Lot Number: UNKNOWN
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/19/2024
• Supplement Date Received by Manufacturer: 06/05/2024
• Initial Report FDA Received Date: 05/14/2024
• Supplement Report FDA Received Date: 06/05/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown